GBR系统
K号: K170697 · 2018-05-24
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申请人Surgident
决定日期2018-05-24
产品代码JEY
咨询委员会DE
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决定实质等同
器械摘要
GBR system is the device name listed in this FDA 510(k) record. The listed applicant is Surgident. It received FDA 510(k) clearance on 2018-05-24 under 510(k) number K170697. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the GBR system?
GBR system is a medical device that received FDA 510(k) clearance on 2018-05-24. The listed applicant is Surgident. The 510(k) number is K170697.
When did GBR system receive FDA 510(k) clearance?
GBR system received FDA 510(k) clearance on 2018-05-24, under 510(k) number K170697.
Who is the listed applicant for GBR system?
The FDA 510(k) record lists Surgident as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GBR system?
The FDA product code for GBR system is JEY.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：JEY）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
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